The OptiMesh 1500E surgical mesh is a Polyethylene Terephthalate (PET) mesh pouch designed to contain impacted granular bone graft and enable its incorporation. The OptiMesh 1500E series mesh is used most commonly for traumatic fracture repair and interbody fusion.
OptiMesh implantation is unique. Using minimally invasive, or even percutaneous, surgical techniques an OptiMesh implant is inserted empty through a small cannula and then packed in situ with bone graft. As more graft is impacted into the mesh, the increasing volume of graft deploys the OptiMesh implant and generates significant distractive force. Then, when completely filled, the OptiMesh implant fibers become taut and granular mechanics, transforms the contained graft into a custom-fit, rigid, load-bearing graft pack.
Over time, graft incorporation occurs through the 1500 micron mesh pores. This can be easily observed as the mesh is radiolucent and compatible with all imaging modalities.
The simple novel design of the OptiMesh system enables physicians to treat a variety of conditions, and in some instances even provide spinal fusion as an outpatient procedure.
OptiMesh Case Examples
MISS Interbody Fusion
Percutaneous Interbody Fusion
Complex Spine
Burst Fracture
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Product Labeling
This product has not been cleared by the FDA for use in the US for the indication shown here.
Graft Incorporation
OptiMesh implants are constructed of radiolucent PET fibers and will not interfere with any imaging modalities.
The G2 AFT graft from MTF used to fill OptiMesh implants is a mixture of cortical chips to provide structure and resistance to compressive loads, Demineralized Bone Matrix and cancellous chips to aid in incorporation, and sodium hyaluronate to help lubricate the bone for easy impaction into the mesh.
Postoperatively, this mixture will provide the appearance of a dense allograft spacer. Clinically what is commonly observed over time is resorption of the allograft bone and a replacement with new bone.
Case Examples:
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Figs. 1 & 2 |
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Figs. 3 & 4 |
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Figs. 5-7 |
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Figs. 8-9 |
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Fig. 10 |
MISS Interbody Fusion
Minimally Invasive Spine Surgery (MISS) means a variety of things to different physicians, but the most universal connotation means surgical decompression and/or fusion through a small, specifically targeted, retractor or portal using direct visualization. MISS technologies aim to minimize incision size and tissue retraction by precisely placing the incision as close to the pathology as possible. This can greatly reduce surgical morbidity and improve the short term surgical outcome.
The Problem: Using conventional interbody fusion systems through small MISS portals can hamper visualization and require more dissection and nerve root retraction than can be easily obtained. Yet, increasing incision, dissection and portal size to accommodate the implant defeats the purpose of an MISS procedure.
The Solution: OptiMesh implantation is performed through a small cannula. This reduces bony dissection and neural retraction requirements enabling good visualization of the operative site when using small MISS portals.
Case Examples:
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OptiMesh is placed through a small cannula, minimizing visual obstruction when using MISS retractors. Click on the image to see the surgical difference. Video provided by Mick J. Perez-Cruet, M.D. |
Percutaneous Interbody Fusion
The percutaneous application of OptiMesh for lumbar fusion can dramatically reduce surgical time and post-operative pain. Making same day, outpatient, lumbar spinal fusion a reality.
Minimally Invasive Spine Surgery offers dramatic benefits over traditional “open” surgery. However, for those patients who do not require direct neural decompression, the implantation of conventional posterior interbody implants still requires bony excision and neural manipulation in order to place the implant. In these cases where direct decompression may not be required, percutaneous OptiMesh implantation is an excellent alternative.
The OptiMesh system instruments enable quick placement of a small portal through a lateral foramen, broad removal of the disc, distraction and indirect decompression of the foramen, and implantation of the mesh and bone.
More Information
Percutaneous Surgical Techniques (coming soon)
Case Examples:
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Percutaneous Interbody Fusion with the OptiMesh Deployable Grafting System |
Complex Spine
One of the greatest challenges that physicians face is good implant “fit”.
In complex spine surgery, disc collapse, hyperlordosis, scoliosis, irregularities in endplate contour, and access limitations secondary to scar from a previous operation are commonplace. These difficult scenarios can make it impossible for an appropriately sized static implant design to be implanted, let alone match endplate contours.
In these scenarios, the OptiMesh system, because of its deployable nature and expanding discectomy equipment, can greatly simplify a difficult procedure.
With the OptiMesh system, a thorough discectomy can be completed through a 7mm portal. In essence, this enables significant preparation of the disc space with a minimum of retraction and placement of an appropriately sized construct that conforms to the cavity created.
Case Examples:
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Before-and-After Images of Lateral DDD Collapse |
Burst Fracture
Traumatic spinal fractures can vary dramatically. Many can be treated conservatively while others may require immediate and extensive surgery. The issue facing the physician is that there are essentially no treatment options between conservative therapy (bracing and bed rest) and corpectomy and/or multilevel posterior fixation.
OptiMesh provides a method by which the physician, for some traumatic fractures, can reconstruct the vertebral body with an OptiMesh and short segment fixation.
This has the potential to offer many patients a surgical option which is significantly shorter and less morbid than a corpectomy.
Case Examples:
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Case 1 |
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Case 2: Before and After |
Burst Fracture Case 2
For some traumatic fractures, OptiMesh with short segment fixation can provide a less invasive alternative to corpectomy.
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OptiMesh Labeling
INTENDED USE / INDICATIONS
OptiMesh is a surgical mesh intended to contain and reinforce bone grafting materials and/or bone graft substitutes in bony voids or gaps of the skeletal system (i.e., the extremities, spine, and pelvis). These voids or gaps may be surgically created osseous defects, natural gaps, or defects partially surrounded by bone, defects created from traumatic injury, or a combination thereof. Adjunct fixation is recommended in cases involving segmental instability.
OptiMesh is indicated for use in orthopedic grafting procedures, including the following:
Lumbar interbody fusion: The OptiMesh 1500 System is used to contain, enhance the compaction of, and stabilize and reinforce bone graft material used in the intervertebral space of patients undergoing fusion to treat degenerative disc disease at one spinal level from L2-S1. For this use, OptiMesh 1500 is to be used in conjunction with stabilizing posterior fixation.
Thoracolumbar vertebral body fractures: OptiMesh 1500 with allograft is intended for vertebral augmentation, including fracture reduction, for the treatment of painful insufficiency fractures of the vertebral body due to osteoporosis, minor trauma or benign lesions.
It is also intended for the treatment of painful traumatic vertebral fractures which are either a) clinically stable upon presentation, or b) are surgically stabilized with posterior fixation.
For a complete listing, see package insert.
Graft Incorporation Figures 1 & 2
Figs. 1 & 2
Post-op and 24 mo x-ray, show replacement of graft and isodense appearance for new bone and vertebra on x-ray.
Graft Incorporation Figures 3 & 4
Figs. 3 & 4.
At 12 mo, graft pack margins commonly show active incorporation. Disc space bridging at the mesh periphery is typically seen first.
Graft Incorporation Figures 5-7
Figure 5-7
Over time a greater percentage of the graft will be replaced with new bone. Initial growth is evident here by 6 mo but to a much greater extent by 2 yrs.
Before-and-After Images of Lateral DDD Collapse
Granular Mechanics
A subspecialty of physics known as Granular Mechanics describes the unique physical characteristics of granular materials.
One useful characteristic of granular materials is their properties change when contained, i.e., flowable (liquid-like) to solid. OptiMesh utilizes this principle.
In an open environment, like the cannulae used to deliver bone into an OptiMesh, the bone granules can flow like a liquid and be pressurized to generate hydraulic-like lifting capabilities. Yet, when a space is enclosed, like the inside of an OptiMesh, the graft granules can be so densely compacted they point load and form force chains, making the graft pack act like a load-bearing solid structure.
Graft Incorporation Figures 8-9
Figs. 8-9
A very mature fusion (28 mo), complete incorporation of allograft pack and calcification of the remaining annulus.
Bust Fracture Case 1
For some traumatic fractures, OptiMesh with short segment fixation can provide a less invasive alternative to corpectomy.
Graft Incorporation Figure 10
